Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
ID07175025

The New Empowerment After eXposure to Trauma (NEXT) Study for Perinatal PTSD Evaluating Narrative Exposure Therapy Versus Usual Care

Led by Indiana University · Updated on 2025-11-19

106

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

Sponsors

I

Indiana University

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a revised perinatal PTSD protocol called Narrative Exposure Therapy (NET) in this pilot randomized controlled study. The study aims to determine the feasibility and acceptability of a brief virtual intervention for pregnant or postpartum women diagnosed with PTSD related to childbirth. Participants are randomly assigned to receive either NET or usual care, with the goal of identifying the most practical and acceptable treatment approach in this group. Participants in the treatment group will receive four sessions of NET delivered virtually. This therapy includes psychoeducation about trauma and PTSD, constructing a life events inventory, exposure sessions where traumatic events are retold and integrated into a personal narrative, and reviewing the full written narrative prepared by the therapist. The usual care group will continue with standard physical and mental health care during pregnancy and postpartum, along with symptom monitoring by study staff. Usual care participants will also receive a list of local mental health support resources and be offered the NET intervention after study assessments. Participants will be assessed at baseline, 12 weeks, and 24 weeks post-baseline to track feasibility, acceptability, and PTSD symptoms. Measures include the Perinatal NET Protocol Acceptability Questionnaire, PTSD Checklist for DSM-5, Edinburgh Postnatal Depression Scale, Life Events Checklist, and Perinatal Quality of Life. Weekly to biweekly symptom monitoring occurs during the 12-week intervention period. The study involves structured calls and questionnaires to monitor progress and safety, with total participation lasting approximately 24 weeks.

CONDITIONS

Brief Title

The New Empowerment After eXposure to Trauma (NEXT) Study

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Able to read and speak English
  • Diagnosis of probable PTSD as determined by the PTSD Checklist for DSM-5 (PCL-5)
  • Pregnant or postpartum (delivered within 16 weeks) at the time of the eligibility screening
Not Eligible

You will not qualify if you...

  • Current severe suicide risk
  • Current psychotic or manic symptoms
  • Cognitive impairment
  • Concurrent trauma-focused psychotherapy
  • Medical advice limiting participation in exposure therapy
  • Current legal actions related to trauma
  • Does not meet criteria for PTSD
  • Not pregnant or delivered more than 12 weeks after timing of eligibility screening

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual) for eligibility assessment

Treatment

Duration - 12 weeks

Participants in the treatment group complete a brief Narrative Exposure Therapy (NET) intervention consisting of four sessions that can be completed virtually. Participants in the usual care group receive symptom monitoring and usual physical and mental health care during pregnancy and postpartum.

Weekly to biweekly visits for therapy sessions or symptom monitoring

Follow-up

Duration - 12 weeks post-treatment

Participants are assessed for feasibility, acceptability, and clinical outcomes after the intervention period.

Visits at 12 weeks and 24 weeks post-baseline for assessments

Trial Site Locations

Total: 1 location

1

Indiana University School of Medicine

Indianapolis, Indiana, United States, 46202

Actively Recruiting

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Research Team

M

Michelle L. Miller, PhD

N

Neva Brown, BA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Narrative Exposure Therapy: Expanding Virtual Treatment of Posttraumatic Stress Disorder to the Postpartum Period.

Michelle L Miller, Rachel S Wasson, Lily J Jiang...

https://pubmed.ncbi.nlm.nih.gov/40395722

Exposure therapy for PTSD during pregnancy: a feasibility, acceptability, and case series study of Narrative Exposure Therapy (NET).

Natalie R Stevens, Michelle L Miller, Christina Soibatian...

https://pubmed.ncbi.nlm.nih.gov/33298159